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Quality control method of scutellaria baicalensis-perilla powder and preparation thereof

A quality control method and content technology, applied in the field of medicine, can solve problems such as complex ingredients, authenticity identification, ingredient analysis, pharmacological research and quality control difficulties, and many impurities

Active Publication Date: 2021-11-09
上海绿谷生命园医药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] However, the composition of traditional Chinese medicine extracts, especially the traditional Chinese medicine extracts of various medicinal materials, is very complex, and there are many impurities, which bring great difficulties to its authenticity identification, component analysis, pharmacological research and quality control.

Method used

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  • Quality control method of scutellaria baicalensis-perilla powder and preparation thereof
  • Quality control method of scutellaria baicalensis-perilla powder and preparation thereof
  • Quality control method of scutellaria baicalensis-perilla powder and preparation thereof

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preparation example Construction

[0244] (1) preparation of test sample solution: accurately weigh the effective part of the described Chinese medicine, solvent dilution and constant volume, microporous membrane filtration, get test sample solution;

[0245] (II) the reference substance solution and the test sample solution are loaded to high performance liquid chromatography and separated,

[0246] Wherein, the separation condition of described high performance liquid chromatography has the following characteristics:

[0247] (i) the chromatographic column is an octadecyl bonded silica gel column;

[0248] (ii) mobile phase is acetonitrile (A) 0.04-0.06wt% phosphoric acid aqueous solution (B);

[0249] (iii) gradient elution;

[0250] (iv) an ultraviolet detection wavelength of 250-300 nm; and

[0251] (III) Analyzing and comparing the chromatograms obtained in step (II) to obtain HPLC sample fingerprints and control fingerprints composed of their common characteristic peaks.

[0252] In the present inven...

Embodiment 1

[0310] 1.1. Prescription

[0311]

[0312] 1.2. Drug preparation and preparation methods

[0313] Take Scutellaria baicalensis medicinal material, add 8 times the amount (weight ratio) of 70% ethanol to water, heat and reflux to extract twice, each time for 2 hours, filter, and the filtrate is decompressed to recover ethanol and concentrate to a relative density of 1.05-1.20 (50-60°C) The extract was dried under reduced pressure (-0.07~-0.1MPa, ≤60°C) to obtain dry extract A.

[0314] Take flavescens medicinal material, add 10 times the amount of 50% ethanol water, heat and reflux to extract twice, each time for 2 hours, filter, and the filtrate is decompressed to recover ethanol and concentrate to a concentrated concentration with a relative density of 1.02-1.12 (50-60°C). liquid. Dilute the concentrated solution with purified water to form a dispersion (containing 0.05kg / L of crude drug), take the dispersion and pass it through a neutral alumina column, elute with 8 tim...

Embodiment 2

[0320] HPLC fingerprint and similarity analysis

[0321] 2.1 Qinsu Capsule HPLC Fingerprint Construction Method

[0322] 2.1.1 Preparation of the test solution

[0323] Take the content of Qinsu capsule, grind it finely, take about 50mg, accurately weigh it, put it in a 25ml brown measuring bottle, add 20ml of 75% methanol, ultrasonicate for 10 minutes (power 250kw, frequency 50KHz), cool to room temperature, add 75% Methanol to the mark, shake well, pass through a 0.45μm microporous membrane, and take the subsequent filtrate to obtain.

[0324] 2.1.2 Chromatographic conditions

[0325] Waters Xbridge Shield RP18 chromatographic column (4.6mm×250mm, 5μm) with octadecyl bonded silica gel as filler; mobile phase: acetonitrile (A)-0.05% phosphoric acid water (B) gradient elution, the gradient conditions are shown in Table 1 ; Detection wavelength: 270nm; Flow rate: 0.8ml / min; Column temperature: 30°C; Running time: 105 minutes (run at the initial concentration for 10 minutes t...

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Abstract

The invention provides a quality control method of scutellaria baicalensis-perilla powder and a preparation thereof. Specifically, the invention provides a quality control method of an effective part of a traditional Chinese medicine, wherein the traditional Chinese medicine comprises the following medicinal materials: scutellaria baicalensis, fructus perillae, caulis perillae, radix sophorae flavescentis and radix salviae miltiorrhizae. The quality of scutellaria baicalensis-perilla powder and a preparation thereof is controlled by controlling the percentage content of a representative active component in the effective part and / or utilizing the similarity of the fingerprint spectra, so that the accurate and comprehensive quality control is achieved.

Description

technical field [0001] The invention relates to the field of medicine, in particular to a quality control method for Qinsu powder and its preparation. Background technique [0002] The traditional Chinese medicine prescription composed of five traditional Chinese medicines including skullcap, perilla seed, perilla stalk, sophora flavescens and salvia miltiorrhiza has various functions such as antipyretic, analgesic and anti-inflammatory. In the prescription, Scutellaria baicalensis is the monarch drug, perilla (children and stalks) and Sophora flavescens are minister drugs, and Salvia miltiorrhiza is an adjuvant drug. The extract obtained by extracting, separating and purifying the Chinese medicinal materials in the above prescription (Qinsu San) has the advantages of less impurities and low side effects, and can be conveniently further prepared into various preparations (such as Qinsu capsules) that are easy to take. [0003] However, the composition of traditional Chinese...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02G01N30/06G01N30/86A61K36/539A61K36/535A61K36/489A61K36/537A61K31/7048A61K31/343A61K31/216A61K31/4375A61K31/352A61K31/58A61P29/00A61P11/14A61P11/00A61P31/04A61P11/10
CPCG01N30/02G01N30/06G01N30/8679G01N30/8686A61K36/539A61K36/535A61K36/489A61K36/537A61K31/7048A61K31/343A61K31/216A61K31/4375A61K31/352A61K31/58A61P29/00A61P11/14A61P11/00A61P31/04A61P11/10A61K2300/00Y02A50/30
Inventor 黄广伟孙仁弟杨素德马云飞杨瑞花张媛媛保红云韦悦高志泓张玥莉
Owner 上海绿谷生命园医药有限公司